medical Class II Updated 2019-01-23

Volcano Corporation recalls Visions PV .035 Digital IVUS Catheter, Catalog Number/Part N

Recalled Product

Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The devices are provided sterile and are single use disposable devices.

Hazard / Issue

Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter.

Issued by

FDA

Distribution: Worldwide Distribution
Lot/Code Info: Batch Numbers: 0301425755 0301418943 0301424426 0301420226 0301425756 0301425758 0301424427 0301418942 0301425757 0301430789 0301430790 0301430792 0301430791 0301420227 0301431656 0301431657 0301431658 0301438592 0301440863 0301438593 0301441405 0301441406 0301442658 0301446207 0301450813 0301450814 0301453531 0301457395 0301457396 0301457397 0301457398 0301465894 0301462001 0301462002 0301462003 0301465896 0301453530 0301465897 0301469598 0301469597 0301469599 0301453529 0301472646 0301472651 0301476733 0301492152 0301487364 0301487363 0301485883 0301485884 0301487964 0301487965 0301481405 0301492153 0301501411
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